Wed, 27 Jan 2021

Palace authorizes FDA to expedite COVID vaccine approval

Philippine Information Agency
04 Dec 2020, 20:38 GMT+10

QUEZON CITY, Dec. 4 (PIA) -- President Rodrigo Roa Duterte issued Executive Order (EO) No. 121 granting an Emergency Use Authorization (EUA) for drugs and vaccines for COVID-19.

This will allow the Food and Drugs Administration (FDA) to grant Emergency Use Authorization (EUA) to expected COVID-19 vaccines that will be made available in the Philippines. The process of approving the vaccines will be shortened to 21 days, which normally takes 6 months.

In a virtual press briefing yesterday, December 3, Presidential Spokesperson Secretary Harry Roque, Jr., he said the EUA will expedite the use of drugs or vaccine against COVID-19 especially those with strong evidence that will benefit the patient.

" [Ang EUA] ay mapapabilis ang pagkakaroon ng paggamit ng mga gamot at bakuna laban sa corona virus lalo na iyong malakas na ebidensya kung saan mag be-benefit ang ating mga pasyente at mapapabilis po ang pag issue ng EUA ng emergency authorization use, under EUA to 21 days [which] normally po kung wala itong EUA it takes us 6 months", Roque said.

("[The EUA] will expedite the availability and use of medicine or vaccine against the corona virus especially those with strong evidence to benefit patients and would fast track the issuance of an EUA to 21 days [which] normally takes 6 months")

Under EO 121, the following are the conditions on the issuance of EUA:

• Based on the totality of evidence available, including data from adequate and well-known controlled trials, it is reasonable to believe that the drug or vaccine may be effective to prevent, diagnose or treat COVID-19;

• The known and potential benefits of the drug or vaccine when used to diagnose, prevent or treat COVID -19 outweigh the known and potential risks of the drug or vaccine, if any;

• There is no adequate, approved and available alternative to the drug or vaccine for diagnosing, preventing or treating COVID-19.

Under EO 121, the President directed the FDA to create a panel of experts on drug and vaccine development that will conduct review of data on the efficacy and safety of the COVID-19 vaccine or drug that will apply for an EUA.

The Secretary also emphasized that the EUA will be valid only within the duration of the declared public health emergency due to COVID-19 pandemic.

In addition to this, Roque added the importance of the EUA citing UK giving EUA approval to Pfizer and starts its vaccination, thus, clarifying that it is not only Pfizer that was issued with EUA but also China issuing EUA to Sinovac and Sinopharm which this only mean that vaccines are already available and close for the country to have it.

"Pero lilinawin ko lang po, hindi po Pfizer ang kauna-unahang-unang nagkaroon ng EUA [ngunit] ang bansang Tsina ay meron ng dalawang bakuna na binigyan ng local na FDA, ito ang Sinovac at Sinopharm [na] ibig sabihin nito naririto na ang bakuna at ginagamit na sa tsina at inglatera at kunting tulog na lang ay darating na sa Pilipinas," Roque added ( MBP/PIA-IDPD)

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